- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Concentrate for solution for intravenous infusion containing amivantamab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Maintenance monotherapy of advanced / metastatic non-small cell lung cancer
Amivantamab is indicated as a monotherapy in the treatment of adults with advanced or metastatic non-small cell lung cancer, with activating epidermal growth receptor Exon 20 insertion mutations and whose disease has advanced during or following platinum-based chemotherapy.
Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.
Doses may vary significantly if this agent is used as monotherapy or different combinations.
When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.
Pre-medication consisting of an anti-pyretic and/or antihistamine should always be administered before each infusion. Pre-medication with corticosteroids should also be considered when these do not form part of the chemotherapy regime.
Additional Dosage Information
Grade 1 to 3: Interrupt infusion. Additional medications such as glucocorticoids, antihistamine, antipyretics and antiemetics, should be administered. Upon symptom relief, resume infusion at 50% of the previous rate. Infusion rate may then be increased per the recommended infusion rate if there are no additional symptoms.
Recurrent Grade 3 or Grade 4: Permanently discontinue.
Interstitial Lung Disease (ILD)/Pneumonitis
Suspected ILD/pneumonitis: Interrupt treatment.
Confirmed ILD/pneumonitis: Permanently discontinue treatment.
Skin and nail reactions
Grade 2: Initiate supportive care. If not resolution after 2 weeks, consider dose reduction.
Grade 3: Initiate supportive care. Interrupt treatment until adverse reaction improves. Upon recovery to Grade 2 or below, treatment may resume at a lower dose. If no improvement within 2 weeks, treatment must be permanently discontinued.
Grade 4: Permanently discontinue.
Other adverse reactions
Grade 3: Interrupt treatment until the adverse reaction improves to Grade 1 or below, or returns to baseline. If recovery occurs within 7 days, treatment may resume at the same dose. If recovery occurs after 7 days, treatment may resume at a reduced dose. If recovery does not occur within 4 weeks, permanently discontinue treatment.
Grade 4: Interrupt treatment until the adverse reaction improves to Grade 1 or below, or returns to baseline. If recovery occurs within 7 days, treatment may resume at the same dose. If recovery occurs after 7 days, consider permanently discontinuing treatment. In the event of recurrent Grade 4 reactions, treatment must be permanently discontinued.
Dose reductions for adverse reactions
Body weight below 80kg
Initial dose: 1050mg
1st dose reduction: 700mg
2nd dose reduction: 350mg
3rd dose reduction: Discontinuation of amivantamab
Body weight 80kg or above
Initial dose: 1400mg
1st dose reduction: 1050mg
2nd dose reduction: 700mg
3rd dose reduction: Discontinuation of amivantamab
Amivantamab is to administered by intravenous infusion via a dedicated line.
Children under 18 years
Precautions and Warnings
Moderate hepatic impairment
Severe renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Consider pre-medication with antihistamines and/or antipyretics
Consider premedication with a corticosteroid
Consider use of corticosteroids if adverse reactions occur
Treatment to be initiated and supervised by a specialist
Concentrate must be diluted and used as an infusion
Consult local policy on the safe use of anti-cancer drugs
Interrupt treatment if infusion reaction occurs & monitor until resolution
Record name and batch number of administered product
Staff: Not to be handled by pregnant staff
Monitor patient for infusion-associated reactions (IARs)
Consider the use of anti-emetics before and during therapy
Discontinue treatment if interstitial lung disease develops
Suspend treatment if grade 3 or worse skin reaction occurs
Suspend treatment if pneumonitis is suspected
Discontinue if grade 3 or greater adverse reaction that recurs/persists
Discontinue if grade 4 skin reaction occurs
Discontinue if treatment related pneumonitis is diagnosed
Suspend treatment if grade 3 or greater adverse reaction occurs
Suspend treatment if interstitial lung disease is suspected
Female: Contraception required during and for 3 months after treatment
Breastfeeding: Do not breastfeed during & for 3 months after treatment
Advise patient on appropriate sun protection methods
Advise patient to limit sun exposure during & for 2 months after treatment
Prior to treatment with amivantamab, the status of EGR Exon 20 insertion mutations should be established by an experienced laboratory.
Pregnancy and Lactation
Amivantamab is contraindicated during pregnancy.
Use of amivantamab during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of amivantamab during pregnancy. However, administration of EGFR and MET inhibitors in pregnant animals has resulted in teratogenic effects. Therefore, potential risks in human pregnancy cannot be ruled out.
Amivantamab is contraindicated in breastfeeding.
Use of amivantamab when breastfeeding is contraindicated by the manufacturer due to the risk of serious adverse reactions in breast-fed infants. The presence of penicillin in human breast milk is unknown. Effects on exposed infants are unknown.
Breastfeeding must be discontinued during treatment and for 3 months after. All breast milk expressed during this period should be discarded.
Alanine aminotransferase increased
Aspartate aminotransferase increased
Increase in serum alkaline phosphatase (reversible)
Infusion related reaction
Interstitial lung disease
Toxic epidermal necrolysis
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2022
Summary of Product Characteristics: Rybrevant (amivantamab) 50mg/mL concentrate for solution for infusion. Janssen-Cilag Ltd. Revised November 2021.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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